Device and method for examining a diabetic foot

ABSTRACT

The invention describes a device and a method for examining the sole of a foot. This invention can be used, for example, for the early detection of neuropathy and/or small wounds on the sole of the feet of diabetic patients. The device comprises a sending means for transmitting images of the sole to, for example, a doctor in a hospital. This enables rapid and simple recording of an image of the sole at home, and using relatively simple means, its transmission to, and examination by an expert at a remote location.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a device, a system and method for checking adiabetic foot. The invention relates in particular to a device forrecording an image of the sole of a foot, comprising image-recordingmeans for creating an electronic image of the sole of the foot.

2. Description of the Background Art

Approximately 15% of diabetic patients sustain a foot wound at one timein the course of their disease and such wounds are often chronic anddifficult to treat. Diabetic patients often have little or no sensationin their feet. This phenomenon is known as “diabetic foot.” If notidentified in time, the tissue damage in a foot wound of a subject,particularly a diabetic patient, can be so extensive as to requireamputation of the leg. Indeed, 40-70% of all lower leg amputations areperformed on diabetics. Early identification and treatment of footwounds in such subjects is therefore very important.

Recording systems for analyzing a diabetic foot generally use pressuresensors to detect problems. German Patent Publication DE 4337608A1discloses a system utilizing pressure sensors. The values measured bythe pressure sensors are sent to a computer for analysis. Such a deviceis relatively expensive requires expertise for operation, making itsuitable only for use in a clinic or hospital. Moreover, such ameasuring apparatus is not suitable for detecting small wounds.

A device described in PCT Publication WO 91/17708 comprises a computerand a visual display unit for examining measured results which includeinformation on the curvature of the sole of the foot. Such measures areemployed for the design and production of a suitable shoe sole. Therecorded image of the sole is converted into a contour map, but theimage, as such, is used no further.

SUMMARY OF THE INVENTION

The present invention is directed to device, system and method thatenables recording of an image of the sole of a foot in a subject,preferably while the subject is at home. This relatively simple deviceprovides a means for having a remotely situated expert collaborate inthe detection/diagnostic process without requiring the subject to go tothe expert.

To that end, the present invention provides a device of the typedescribed herein, and in the appended drawings, that comprises sendingmeans for sending the electronic image to a remote monitor.

In a preferred embodiment, the device contains no sensors, but onlyimage-recording means, for recording an image of the sole of the foot.Sending the electronic image enables remote monitoring, for example by adoctor, who can examine the sole of the foot and take any necessaryaction. Sending images regularly ensures monitoring over time so thatany changes such as deterioration in the condition of the sole can bedetected in time.

The device preferably comprises a transparent support surface, forsupporting a foot. A subject can easily place his/her feet on thesupport surface, after which a image of the sole is made.

In one embodiment the electronic image comprises or can be converted toa color photograph or of the sole of the foot. Color information isdesirable during the examination of diabetic feet.

In another embodiment the device comprises a connection for a televisionand/or a computer. In this case a subject can himself/herself view animage using commonly available equipment, such as a TV set or a personalcomputer.

Diabetic patients often have impaired vision, so that theimage-recording means in one embodiment of the invention comprisestuning means to permit zooming in on, or zooming out from, the sole ofthe foot. With this device, a monitor can study the sole in greatdetail, making early detection of a small wounds more likely.

In a further embodiment the device comprises a regulating means, whichis designed to communicate with the image-recording means, in order tocontrol the image-recording means remotely. The regulating device canbe, for example, a remote control, the use of which enables a subjectstanding on the device or resting a foot on the device's recordingsurface to control the zooming in or out of the image, and/or therecording and transmission of an image.

In a further embodiment the transparent supporting surface is placed ona box-shaped construction containing the image-recording means. In thisway the device is very practical because the image-recording means isprotected.

In one embodiment the device includes switching means, which is designedto activate the image-recording means after pressure has been exertedupon the supporting surface. All a subject now has to do is place a footor feet on the device and a image of one or both soles will be acquired.

In a preferred embodiment the sending means is designed for sending adigital copy by way of a digital network, such as the Internet. Thesending means comprises, for example, a modem for sending digitalsignals via telephone line. An image can then be sent, via the Internetfor example, directly to a doctor or another suitable person. This canspare the subject the need to visit the doctor. It will be clear thatthe modem can be a wireless or telephone modem. In this case, the deviceis a stand-alone apparatus, which can also be used outdoors.

The invention also provides a method for examining the sole of a foot,using the following steps:

-   -   (a) making an electronic image of the sole of a foot of a        subject with the aid of the image-recording means;    -   (b) sending the electronic image to a remote monitor;    -   (c) examining the sole of the foot by viewing the monitor.

The examining process can further comprise the following:

-   -   (d) detecting any small wounds that may be present on the sole        of the foot;    -   (e) comparing the condition of the sole of the foot with results        of any previous examination of the sole

The subject of the foot sole examination can preferably also views theelectronic image himself/herself on a visual display unit that can beconnected.

The present invention also to the use of a foot sole recording devicefor examining a diabetic foot, said device comprising image-recordingmeans for making an electronic image of the sole, wherein the devicecomprises sending means for transmitting the electronic image to aremote monitor.

The invention also includes a monitoring system comprising:

-   -   1. a communication network;    -   2. a foot sole recording device configured to create an        electronic image of the sole send he electronic image into the        communication network;    -   3. a monitoring device configured to receive the electronic        image from the communication network, and to display the image.

The monitoring system enables remote examination of diabetic feet. Forexample, a doctor in a remote hospital location is able to examine asole without requiring that the subject visit the hospital.

Further advantages and features of the present invention will becomeclear on inspecting the description of a preferred embodiment, withreference to the appended drawings

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a device according to the invention;

FIG. 2 is a top view of a device according to the invention.

FIG. 3 is a side view of a preferred embodiment of the invention;

FIG. 4 is a diagram of a monitoring system according to an aspect of theinvention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a side view of an embodiment of the device according to theinvention. The device 1 comprises a transparent supporting surface 11,made of, for example, glass. A foot 12 can be placed on the supportingsurface 11. The device 1 comprises a video camera 13, which is directedat the transparent supporting surface 11. The transparent supportingsurface 11 is preferably supported on a box-shaped construction 15. Thedevice 1 comprises sending means 10, for example a modem, fortransmitting image information to a remote monitor. In a preferredembodiment, the sending means 10 is/are connected to an output port ofthe video camera 13. The sending means can comprise a modem, which canbe connected to a computer network, such as the Internet, so that therecorded image can be sent to a remote target, for example, a doctor.The latter can then examine the image and, if necessary, invite the userof the device 1 for further examination. An address of the examiningdoctor to which the data is to be sent may be input in advance, possiblyby a supplier. Since privacy and confidentiality of data about anysubject's condition is generally desired, the data preferably are sentin encoded form. The device can also comprise a switching means 20, suchas a switch, which is connected to the camera 13, and is designed sothat when pressure is exerted upon the supporting surface 11, the camera13 is engaged or activated, optionally after a delay.

In one embodiment the device 1 comprises a (wireless) connection 14 ofthe video camera 13 to a display means such as, for example, atelevision. The device 1 preferably also comprises a regulating device16, such as a remote control, for remote control of the video camera 13.The device 1 comprises light means 17 for illuminating the sole.

For user of the device 1 to see the images, the device 1 must beconnected to, for example, a television unit. If the connection 14 is acable, the user must see to it that the cable is connected to an inputport of the television. In the case of wireless communication, thewireless connection 14 only need be activated. The television monitorand the video camera 13 then must be switched on and the correct channelselected on the television; this is usually the video channel.

The user then places one or both feet on the supporting surface 11. Thesupporting surface 11 preferably forms an angle with the horizontalplane, so that it is convenient for a subject sitting in a chair toplace his feet on the device 1 without exerting too much pressure on thesupporting surface 11. When the feet have been placed, the soles becomevisible on the TV screen. The user can now increase or reduce the sizeof the image, if desired, using the regulating device 16. In anotherembodiment the sole can be displayed on the visual display unit of acomputer. If the correct software and control programs have been loaded,the user can examine the images and store them on, for example, a harddrive of the computer. The video camera 13 can be a digital videocamera, an electronic photographic camera or a digital photographiccamera. The image-recording means can be a flatbed scanner, preferablyconnected to a computer.

In a preferred embodiment, the device 1 comprises a toe-spreading device21, which consists of a preferably transparent mat 23 on whichelevations or protrusions 22 are provided. The way in which thetoe-spreading device 21 operates can be seen more clearly in FIG. 2. Thetoe-spreading device 21 can be placed on the transparent supportingsurface 11, as is shown in FIG. 1. The toe-spreading device preferablycomprises several elevations or protrusions 22, which are, for example,in the shape of a cylinder. The toes of the user are placed verticallyon the device, so that when they contact the elevations or protrusions22, the toes are moved apart, producing larger inter-toe intervals. Inthis example the toe-spreading device comprises 4 elevations per foot,but fewer elevations are also contemplated.

The device can also comprise positioning means 24 for positioning thefoot 12. A user can consequently position one or both feet 12 to providea good view of the soles. The positioning means 24 can consist of twocurved lines placed on the supporting surface 11 or on the mat 23.Alternatively, the positioning means 24 could also comprise twooptionally curved, upright arches, against which the heels are placed.

FIG. 3 shows a side view of a preferred embodiment of the device,wherein the device 1 comprises a triangular shaped box comprising a heelsupport 31 which is configured to activate a pressure sensor 32 whenpressure is exerted on the heel support 31. The heel support 31 isconfigured to receive a heel of a foot, in such a way that the sole ofthe foot remains fully visible to the lens or other recording means ofcamera 33 present in the triangular shaped box 30. The pressure sensor32 is configured to activate the camera 33. The device 1 may have one ortwo heel supports 31. If the device 1 has only one heel support, a userwill have to switch feet in order to record images of both foot soles.Using a device 1 as shown in FIG. 3, a person can examine the sole ofhis foot while sitting a chair. This is very convenient, particularlyfor diabetic patients or others with limited mobility.

FIG. 4 is a diagram of a monitoring system 40 according to theinvention. The monitoring system 40 comprises a communication network41, such as the Internet, and a food sole recording device 42 configuredto create an electronic image of the sole. The device 42 is configuredto send an electronic image to or into the communication network 41. Thedevice may comprise, for example, a mobile communication device (notshown in this drawing), which is configured to connect to thecommunication network 41 via a telephone line. The monitoring system 40preferably further comprises a monitoring device 45 configured toreceive the electronic image from the communication network 41, and todisplay the electronic image.

Preferably, the monitoring device 45 comprises memory (not shown in thisdrawing) for storing electronic images. Furthermore, the monitoringdevice 45 may be configured to display (e.g., on a screen) theelectronic images together with previously received and recorded images.In this way a doctor, or other health professional, can compare imagesand determine whether a foot, such as a diabetic foot, is deterioratingover time. If the health professional discerns the need for directaction, he can call the subject into the hospital or other medicalfacility. If no change, or only minor changes are noted, the healthprofessional may choose not to bring the subject in for a face-to-facemeeting. Rather, the health professional can elect to phone the subjectto discuss or check his status.

In one embodiment, the food sole recording device 42 is configured tosend identification information identifying the recording device 42and/or a user (not shown in this drawing) to the monitoring device 45.The monitoring device 45 may be configured to file the electronic imagesof one subject, in order to organize data by individual subjects fromwhom the images are obtained. This can be accomplished by reading theidentification information which is sent by the recording device 42together with the electronic images and storing them in a suitablydesigned database. Such databases are well-known in the art.

The camera can, for example, be set to record several images afteractivation and to send those that meet a desired criterion (such assharpness of image). Light means that emits light of a certainwavelength may be used. For example, infrared light can be used, tocreate a temperature profile of the sole. This temperature profile maybesent together with a true copy of the image of the sole, so that ahealth professional or other recipient of the data has additional usefulinformation. Monochromatic light may also be used. Drying of the solecan be detected most easily with the aid of ultraviolet light. Otherwavelengths are also useful, so that, for example, underlying structuresin the sole can be made visible. Alarm means may also be included toalert the subject, for example, to the fact that a photograph should bemade and sent. The device can also comprise another alarm means toremind the subject at regular, predetermined intervals to examine hisfoot or feet. This assures regular transmission of an image to anexamining point, such as to a health professional. In addition, thedevice may be equipped to transmit identification data, to clearlyidentify to a receiving health professional, computer or database theidentity of the subject whose image has arrived or will arrive.

Any references cited above are all incorporated by reference herein,whether specifically incorporated or not.

Having now fully described this invention, it will be appreciated bythose skilled in the art that the same can be performed within a widerange of equivalent parameters and conditions without departing from thespirit and scope of the invention and without undue experimentation.

1. A device for recording an image of the sole of a foot, comprisingimage-recording means for making an electronic image of the sole of thefoot, wherein the device comprises sending means for sending theelectronic image to a remote monitor.
 2. The device according to claim1, which comprises a transparent foot supporting surface.
 3. The deviceaccording to claim 1, in which the electronic image comprises a colorphotograph of the sole of the foot.
 4. The device according to claim 1,in which the device comprises a connection for a television and/or acomputer.
 5. The device according to claim 1, wherein theimage-recording means comprises tuning means to permit zooming in orzooming out the image of the sole.
 6. The device according to claim 1,which comprises a regulating device, that communicates with theimage-recording means, in order to control the image-recording meansremotely.
 7. The device according to claim 1, which comprises switchingmeans, that activate the image-recording means after pressure has beenexerted thereupon.
 8. The device according to claim 1, in which thesending means sends a digital image of the sole by way of a digitalnetwork.
 9. A monitoring system comprising: (a) a communication network;(b) a recording device according to claim 1 configured to create anelectronic image of a sole of a foot and to send said electronic imageinto said communication network; (c) a monitoring device configured to(i) receive said electronic image from said communication network, and(ii) display said electronic image.
 10. A system according to claim 9,wherein said monitoring device comprises memory for storing data, saidmonitoring device being configured to (i) store electronic images insaid memory; and (ii) display said electronic image and to display animage of a foot sole received earlier from a foot sole recording device.11. A system according to claim 9, wherein said recording device isconfigured to send to said monitoring device information thatidentifies: (i) said recording device; and/or (ii) a user of saidrecording device.
 12. A system according to claim 9, wherein saidmonitoring device is configured to file and/or store said electronicimage together with other electronic images being associated with thesame identifying information.
 13. A method for examining the sole of afoot in a subject, comprising the steps of: (a) creating an electronicimage of the sole of the subject using the device and theimage-recording means of claim 1; (b) sending the electronic image to aremote monitor; (c) examining the sole by viewing the image on themonitor.
 14. A method according to claim 13, wherein the examiningfurther comprises: (d) detecting or identifying any small wounds presenton the sole as detected in said image; (e) comparing the image of saidsole with an image of the sole of the foot of said subject examined at aprevious examination.
 15. A method according to claim 13, configured sothat said subject can monitor the image on a visual display unit.
 16. Amethod according to claim 13, which comprises the step of positioning ofthe foot relative to the image-recording means.
 17. The method accordingto claim 13, wherein the subject has diabetes.
 18. A method forexamining a diabetic foot, comprising carrying out the method of claim13 on a the foot or feet of a diabetic subject.
 19. A method forexamining a diabetic foot, comprising carrying out the method of claim14 on the foot or feet of a diabetic subject.
 20. A method for examininga diabetic foot, comprising using the device of claim 1.